Heart Disease Trial, Recruiting NCT04606459 Sponsor: Johannes Gutenberg University Mainz Condition: Heart Disease
Back to Heart Disease

Heart Disease Trial, Recruiting

NCT04606459
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged between 18 and 85 years old
  • People who have a long-term heart condition causing chest pain or similar symptoms (called chronic coronary syndrome) that remains severe (classified as CCS class III or IV) despite already receiving the recommended medications
  • People whose tests show areas of the heart that are not getting enough blood flow, but where this can improve (called reversible ischemia)
  • People whose tests done inside the heart's blood vessels show that the very small blood vessels in the heart are not working properly (this is measured using specific tests called IMR, CFR, and FFR — confirm details with trial site)
  • People who are willing to take part and are able to read, understand, and sign the consent form before joining

Who may not be able to join:

  • People who have had a heart attack or serious heart event in the last 3 months
  • People who have had a procedure to open or bypass heart arteries (such as a stent or bypass surgery) in the last 6 months
  • People who had an unsuccessful stent procedure in the last 30 days
  • People whose heart failure is currently unstable, or who were admitted to hospital for heart failure in the last 3 months
  • People whose heart pumping strength is very low (below 30%)
  • People with high pressure in a specific heart chamber (right atrial pressure above 15mmHg)
  • People whose heart vein (coronary sinus) has an unusual shape or structure, as seen on imaging
  • People whose coronary sinus vein is either too wide (over 13mm) or too narrow (under 9.5mm) at the planned treatment site, as measured on imaging
  • People with severe lung disease where breathing tests show the lungs are working at less than 55% of expected capacity
  • People with severe heart valve disease
  • People who have a pacemaker wire running through the coronary sinus vein
  • People who have had their tricuspid heart valve replaced or repaired
  • People with serious long-term kidney disease or who are on regular dialysis
  • People who are very unwell or have other serious illnesses where life expectancy is less than one year
  • People with a known serious reaction to medications required for the procedure
  • People with a known allergy to stainless steel or nickel
  • People who will need an MRI scan within 8 weeks after the device is implanted
  • People for whom a specific type of blood-thinning medication combination (dual antiplatelet therapy) is not suitable
  • Women who are able to become pregnant (those who have had a period in the last 12 months and have not had their tubes tied, ovaries removed, or a hysterectomy)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +496131172829

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Johannes Gutenberg University Mainz
Registry
ClinicalTrials.gov
Start date
1 April 2021
Est. completion
20 October 2025

Where this trial is recruiting

🇩🇪 Germany

Primary endpoints

Change in Canadian Cardiovascular Society angina class by two or more classes

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov